Nonin 3150 Operator's Manual

Operator’s Manual

0123

WristOx

Wrist-Worn Pulse Oximeter

with Bluetooth

Model 3150

™

Pulse Oximeter

2

®

Wireless Technology

English

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a

EC

REP

licensed practitioner.

Consult Instructions for Use.

Nonin® reserves the right to make changes and improvements to this manual and the products it
describes at any time, without notice or obligation.

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, MN 55441-5443

USA

+ 1 [phone]

800-356-8874 (USA and Canada)

Fax: + 1 [phone]
e-mail: [e-mail]

www.nonin.com

0123

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

References to “Nonin” in this man
Nonin, WristOx

Medical, Inc. The Bluetooth
of such marks by Nonin Medical, Inc. is under license. Other trademarks and trade names are
those of their respective owners.

, PureLight, and nVISION are registered trademarks or trademarks of Nonin

2

word mark and logo are owned by the Bluetooth SIG, Inc. and any use

ual imply Nonin Medical, Inc.

© 2010 Nonin Medical, Inc.

7622-001-01

Contents

Indications for Use.................................................................................................... 1

Contraindications....................................................................................................1

Warnings ................................................................................................................1

Cautions .................................................................................................................2

Declaration of Conformity with FCC and Canadian Ministry

of Health Rules for Electromagnetic Compatibility..............................................3

Federal Communications Commission (FCC) Notice............................................. 3

Guide to Symbols...................................................................................................... 4

Displays, Controls, and Indicators.......................................................................... 5

Introduction ...............................................................................................................8

Unpacking the WristOx

Standard Kit....................................................................................................... 8

Starter Kit .......................................................................................................... 8

Batteries ................................................................................................................ 9

Bluetooth Technology............................................................................................ 9

Operation Modes.....................................................................................................10

Cable ................................................................................................................... 10

Standby .............................................................................................................. 10

On........................................................................................................................ 10

Spot Check Mode ............................................................................................ 10

Sensor Activation Mode................................................................................... 11

Programmed Mode.......................................................................................... 11

Using the WristOx

, Model 3150............................................................................ 12

2

Installing Batteries............................................................................................... 12

Wrist Straps......................................................................................................... 13

Ring Strap Description..................................................................................... 13

Attach Ring Strap to Device............................................................................. 14

Adjustable Strap Description............................................................................ 15

Attach Adjustable Strap to Device ................................................................... 15

Attaching the Sensor........................................................................................... 18

Patient Application............................................................................................... 19

Two-Piece Wrist Band Application................................................................... 19

Single Strap Application................................................................................... 21

Verifying Operation.............................................................................................. 24

Startup Sequence and Self-Test.......................................................................24

Activation Switch ................................................................................................. 25

Activate Bluetooth Radio.................................................................................. 25

Activate Device ........................................................................................ ........ 25

Error Codes......................................................................................................... 25

Troubleshooting..................................................................................................... 26

Care and Maintenance............................................................................................ 28

Cleaning the Device ............................................................................................ 28

Cleaning the Sensor............................................................................................ 28

Cleaning the Wrist Band...................................................................................... 28

Storing................................................................................................................. 28

, Model 3150 ....................................................................8

2

i

Contents (Continued)

Memory and Data.....................................................................................................29

nVISION Software ....................................................................................................30

nVISION Settings................................................................................................. 30

Accessing nVISION Settings............................................................................ 30

Cable Connection................................................................................................. 31

USB Driver Installation (XP) ............................................................................. 32

USB Driver Installation (Vista).......................................................................... 32

USB Driver Installation (Windows 7)................................................................. 33

Bluetooth Connection........................................................................................... 33

Parts and Accessories ........................................................................................... 35

Service, Support, and Warranty ............................................................................ 36

Service and Support............................................................................................. 36

Warranty............................................................................................................... 36

Technical Information............................................................................................. 37

Manufacturer’s Declaration................................................................................ 37

Equipment Response Time................................................................................ 40

Testing Summary............................................................................................... 41

SpO

Accuracy Testing .................................................................................. 41

2

Pulse Rate Motion Testing.............................................................................. 41

Low Perfusion Testing.................................................................................... 41

Specifications..................................................................................................... 42

Oximeter Specifications.................................................................................. 42

System Specifications..................................................................................... 43

Transmitter ..................................................................................................... 44

ii

Figures

Figure 1. Front Display (Startup Screen).............................................................. 5

Figure 2. Comparison of Full and Partial Display................................................11

Figure 3. Remove Battery Door.......................................................................... 12

Figure 4. Insert Batteries.................................................................................... 12

Figure 5. Ring Strap........................................................................................... 13

Figure 6. Thread Ring Strap............................................................................... 14

Figure 7. Attach Ring Strap................................................................................ 14

Figure 8. Adjustable Strap.................................................................................. 15

Figure 9. Thread Adjustable Wrist Strap............................................................ 16

Figure 10. Attach Adjustable Wrist Strap ........................................................... 16

Figure 11. Device with Wrist Straps Attached (Front and Back Views).............. 17

Figure 12. Attach Sensor.................................................................................... 18

Figure 13. Verify Two-Piece Wrist Band Attachment......................................... 19

Figure 14. Thread and Tighten Two-Piece Wrist Band...................................... 20

Figure 15. Fasten Two-Piece Wrist Band........................................................... 20

Figure 16. Apply Sensor to Patient .................................................................... 21

Figure 17. Verify Single Strap Attachment......................................................... 21

Figure 18. Thread Single Strap ......................................................................... 22

Figure 19. Tighten Single Strap.......................................................................... 22

Figure 20. Fasten Single Strap........................................................................... 23

Figure 21. Apply Sensor to Patient..................................................................... 23

Figure 22. nVISION Settings Window................................................................. 31

Tables

Table 1. Labeling Symbols.................................................................................. 4

Table 2. Error Codes......................................................................................... 25

Table 3. Electromagnetic Emissions................................................................. 37

Table 4. Electromagnetic Immunity................................................................... 38

Table 5. Guidance and Manufacturer’s Declaration—

Electromagnetic Immunity ................................................................39

Table 6. Recommended Separation Distances................................................. 40

iii

Indications for Use

Indications for Use

The Nonin Model 3150, WristOx

™

Pulse Oximeter is a small, wrist-worn device indicated for

2

use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin
(%SpO

) and pulse rate of adult and pediatric patients. It is intended for spot-checking and/or

2

data collection and recording of patients during both no motion and motion conditions, and for
patients who are well or poorly perfused. The intended use environments are sleep and
pulmonary rehab labs, surgical recovery, critical care, emergency room, long-term care, home
use, and mobile units.

Contraindications

Do not use this device in a Magnetic Resonance (MR) environment or in the presence of flammable anesthetics or
gases.

This device is not defibrillation proof per IEC 60601-1:1988/A2:1995 clause 17h.

Warnings

This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other
methods of assessing clinical signs and symptoms.

Carefully route patient cables and connections to reduce the possibility of patient entanglement or strangulation.

®

Use only Nonin-branded PureLight
accuracy specifications for Nonin pulse oximeters. Using other manufacturers’ sensors can result in improper pulse
oximeter performance.

pulse oximeter sensors. These sensors are manufactured to meet the

This device is a precision electronic instrument and must be repaired by qualified technical professionals. Field
repair of this device is not possible. Except to replace batteries, do not attempt to open the case or repair the
electronics. Opening the case may damage the device and void the warranty.

The USB cable must be unplugged from the device before replacing batteries.
This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary,

the device should be observed carefully to verify normal operation.
The use of accessories, sensors, and cables other than those listed in this manual may result in increased

electromagnetic emission and/or decreased immunity of this device.
Do not use the device when alarms are required.

Do not use a damaged sensor.
This equipment complies with International IEC 60601-1-2:2007 for electromagnetic compatibility for medical

electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful
interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels
of such interference due to close proximity or strength of a source might disrupt the performance of this device.
Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and
put into service according to the EMC information specified in this manual.

Only use Nonin-branded sensors with a length of 1 meter or less. Accuracy may degrade if sensor cable is over 1
meter in length. Using the sensor cable adapter does not affect accuracy.

1

Indications for Use

Cautions

If this device fails to respond as described, refer to “Troubleshooting” or discontinue use until the situation has been
corrected. Contact Nonin Technical Service.

This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as
good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality.

Check the pulse oximeter sensor application site every 6-8 hours to determine the positioning of the sensor and the
circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or skin condition.

Do not place liquids on top of this device.
Do not place the WristOx

alcohol. Refer to the “Care and Maintenance” section of this operator’s manual.
Use a detergent that is safe for skin and washable surfaces. Most detergents can be high sudsing, so use sparingly.

Wipe with a damp, detergent free cloth to remove residue.
Follow local, state, and national governing ordinances and recycling instructions regarding disposal or recycling of

the device and device components, including batteries.
In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do

not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your
distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call
Nonin for your distributor’s contact information.

This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors
that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:

• excessive ambient light

• excessive motion

• electrosurgical interference

• blood flow restrictors (arterial catheters, 
blood pressure cuffs, infusion lines, etc.)

• moisture in the sensor

• improperly applied sensor

• incorrect sensor type

Do not perform any testing or maintenance on this device while it is being used to monitor a patient.
Verify all visible indicators appear during the start-up (initialization) sequence. If any indicator does not appear, do

not use the device. Contact Nonin Technical Service for assistance.

, Model 3150, in liquid or clean it with agents containing ammonium chloride or isopropyl

2

• poor pulse quality

• venous pulsations

• anemia or low hemoglobin concentrations

• cardiogreen and other intravascular dyes

• carboxyhemoglobin

• methemoglobin

• dysfunctional hemoglobin

• artificial nails or fingernail polish

Portable and mobile RF communications equipment can affect medical electrical equipment.
Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for

more than 30 days. Do not use different types of batteries at the same time. Do not mix fully charged and partially
charged batteries at the same time. These actions may cause the batterie s to le ak.

To avoid the risk of confusing or misinterpreting patient data when transmitting data via Bluetooth, verify the device
is paired with the correct display unit.

The pulse oximeter may not work when circulation is reduced. Warm or rub the finger or reposition the sensor.
A functional tester cannot be used to assess the accuracy of the oximeter or sensor.
Do not fasten the device too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could

result.

2

Indications for Use

Declaration of Conformity with FCC and Canadian Ministry of
Health Rules for Electromagnetic Compatibility

• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares
under its sole responsibility that Model 3150, WristOx
declaration relates, complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation.

• Ministry of Health (Canada), Safety Code 6: standards include a substantial safety
margin designed to ensure the safety of all persons, regardless of age and health. The
exposure standard for wireless mobile phones employs a unit of measurement known
as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg.

Pulse Oximeter, to which this

2

Federal Communications Commission (FCC) Notice

This device has been tested and found to comply with the limits for a class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This device generates,
uses, and can radiate radio frequency energy. If not installed and used in accordance with
the instructions, it may cause harmful interference to radio or television reception, which
can be determined by turning the device off and on. The user is encouraged to try to correct
the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the distance between the device and the receiver.

• Connect the device to an outlet on a circuit different from the outlet where the receiver
is connected

• Consult the dealer or an experienced radio/TV technician for assistance.

• RF Exposure: For body worn operation, to maintain compliance with FCC RF exposu re
guidelines, use only accessories that contain no metallic components. Use of other
accessories may violate FCC RF exposure guidelines and should be avoided.

• The WristOx2, Model 3150, is designed and manufactured not to exceed the emission
limits for exposure to radio frequency (RF) energy set by the United States FCC. These
limits are part of comprehensive guidelines and establish permitted levels of RF energy
for the general population. The guidelines are based on the safety standards previously
set by both U.S. and international standards bodies. This device has been shown to be
compliant for localized specific absorption rate (SAR) for uncontrolled environment/
general population exposure limits specified in ANSI/IEEE Std. C95.1-2005.

• The FCC requires the user to be notified that any changes or modifications to this device
that are not expressly approved by Nonin Medical, Inc. may void the user’s authority to
operate the device.

3

Guide to Symbols

!

EC

REP

0123

Guide to Symbols

This chapter describes the symbols that are found in this manual and on the WristOx2,
Model 3150. Detailed information about display symbols can be found in “Displays,
Controls, and Indicators.”

Table 1: Labeling Symbols

Symbol Description

Caution!

Consult Instructions for Use.

Authorized Representative in the European Commun ity.

CE Marking indicating conformance to EC dir
concerning medical devices.

Type BF-Applied Part (patient isolation from electrical shock)

No alarms

Indicates separate collection for electrical and electronic equipment

Continua Certified™ sign
be interoperable with other products that carry the Continua Ce rtified symbol.

®

Bluetooth

Non-ionizing electromagnetic radiation. Equipment includes RF transmitters.
In

terference may occur in the vicinity of equipment marked with this symbol.

UL Mark for Canada and the United S tates w
and mechanical hazards only in accordance with UL 60601-1 and 
CAN/CSA C22.2 No. 601.1.

®

figure mark

ifies that this product has been tested and proven to

ective No. 93/42/EEC

ith respect to electric shock, fire,

(WEEE).

IP33

4

Protected against spraying water and against access to hazardous p arts with
a tool, per IEC 60529.

Activation Switch

Sensor Port

Displays, Controls, and Indicators

Displays, Controls, and Indicators

Figure 1: Front Display (Startup Screen)

%SpO2 Display

This 3-digit display, located in the upper left corner of the LCD, 
shows percent blood oxygen saturation (%SpO
from 0 to 100 %.

This display also shows the month, year, and hour (24-hour clock
format) during startup.

). The range is 

2

Pulse Rate Display

This 3-digit display, located below the %SpO2 display, shows the
pulse rate in beats per minute (BPM). The range is from 18 to 32 1
BPM.

This display also shows the day and minute during startup.

5

Full

Half

Critical

Low

Displays, Controls, and Indicators

Activation Switch

This switch is located next to the sensor port.
Pressing this switch activates the Bluetooth radio for 3 minutes.
It can also be used to turn the device on when it is in Standby mode.

See “Activation Switch” section for more information.

Sensor Fault Indicator

This indicator displays if the device determines a sensor fault exists
(e.g., sensor disconnect, misalignment, or incompatibility with the
device). It also displays when the finger is removed from the sensor.

Pulse Strength Indicator

This heart-shaped indicator is followed by up to nine curved bars. The
heart shape is always visible, and the number of curved bars on the
display depends on the pulse strength as determin ed by the oximeter.

Poor Pulse Signal Indicator

This indicator displays when the pulse signal is inadequate or the
device does not sense a pulse. It may also display if there is
excessive motion at the sensor site.

Battery Indicator

This indicator shows remaining battery life as eithe r full, half, low, and
critical (as shown at left).

Replace the batteries when device reaches low state.
When the battery reaches critical state, all indicators clear from the

display except for the blinking critical battery indicator, the current
session closes, and the Bluetooth radio shuts down.

6

Bluetooth

indicator

Bluetooth indicator
with animated bars

Displays, Controls, and Indicators

Bluetooth Indicator

This indicator displays when the Bluetooth radio is on. It appears as
either the Bluetooth logo or the Bluetooth logo with animated bars.

This indicator displays for the first 2 minutes the device is on. If a
master device does not connect to the device in those 2 minutes, the
Bluetooth radio shuts down and the icon no longer displays.
When the device is connected to a master device, the indicator
displays with animated bars.

If the Bluetooth radio is on when the device enters Standby mode or
connects to the USB interface cable, the Bluetooth indicator appears
on the LCD while the Bluetooth radio shuts down. It will be the only
indicator on the LCD and will display for up to 10 seconds.

SmartPoint Indicator

This indicator displays during the startup sequence.

7

Introduction

Introduction

The Bluetooth-enabled WristOx2, Model 3150, is a small, wrist-worn device that displays,
measures, and stores patient SpO
radio with a range (spherical radius) of approximately 100 meters (328 feet).

The device ships ready to use in Spot Check turn on mode. In Spot Check turn on mode,
inserting a finger in the sensor automatically turns the device on. Approximately 10
seconds after the finger is removed, the device enters Standby mode.

Advanced memory and programming features are available with Nonin’s nVISION®
software (version 6.3 or greater). See the “nVISION Software” section to learn more about
using the device with nVISION.

Unpacking the WristOx2, Model 3150

The WristOx2, Model 3150, standard or starter kit includes the items listed below . Once the
shipping carton is unpacked, verify these items were received. Contact the carrier
immediately if the shipping carton is damaged.

and pulse rate data. The device includes a Bluetooth 

2

Standard Kit

• Model 3150, WristOx2 Pulse Oximeter

• Model 8000SM-WO2, reusable soft sensor

• 3 two-piece wrist bands, 1 each of the following:

• 6 in. (15 cm)

• 8 in. (20 cm)

• 10 in. (25 cm)

• 2 AAA (1.5 volt) alkaline batteries

• Operator’s manual (CD)

• USB driver software (on operator’s manual CD) – required to use the PC USB interface cable

Starter Kit

A starter kit is required to configure the device and download data to a PC. The starter kit
consists of the standard kit, plus:

• 9 pack of two-piece wrist bands, 3 each of the following:

• 6 in. (15 cm)

• 8 in. (20 cm)

• 10 in. (25 cm)

• nVISION SpO2 data management software (CD)

• PC USB interface cable

8

Introduction

Batteries

The device uses 2 AAA alkaline batteries.
With new alkaline batteries, battery life is approximately 48 hours (minimum) when not

connected to a Bluetooth device. When connected to a Bluetooth device, battery life will
vary depending on class of operation. See “Specifications” for detailed battery life
information.

The battery indicator shows one of four states: full, half, low, and critical. Replace the
batteries when device reaches low state. A low battery has a minimum of 10 minutes
before it reaches critical state. Actual battery life depends on Bluetooth radio use. In critical
battery mode, the battery indicator blinks and the device no longer monitors or records
patient data.

When batteries are removed, the device maintains the time and da te for up to 30 seconds.
If replacing batteries takes more than 30 seconds, or if the battery level is at or below the
critical level, clock settings are lost and the device reverts to Spot Check mode. Use
nVISION software to reset the clock and change the operation mode.

Remove the batteries and disconnect the sensor if the device is to be stored for more than
1 month. In storage, battery life is approximately 9 months.

NOTES:

• This device contains non-volatile memory. Removing or replacing batteries does not
affect the data stored in memory. Stored data remains in memory until overwritten by
newer data or cleared from memory with nVISION software (version 6.3 or greater).

• If batteries are replaced while recording data, the session will terminate and some data
from the session may not be saved. The terminated session will be time stamped with
the current date/time the next time the device turns on.

• If clock settings are lost, the date and time restarts at 01:01:10:00:00.

Bluetooth Technology

Bluetooth technology allows wireless connections between electronic communications
and computing devices. The technology is based on a radio link that offers fast and reliable
data transmissions. Bluetooth uses a license-free, globally available frequency range in
the ISM band—intended to ensure communication compatibility worldwide.

Nonin’s use of Bluetooth wireless technology allows SpO2 and pulse rate data to be
transmitted through a Bluetooth radio to a compatible Bluetooth-enabled device. Nonin’s
wireless system removes the cable connection from the device, giving patients increased
ability to move freely.

To make efficient use of battery life, Nonin’s WristOx2, Model 3150, uses an automatically
switchable Class 1/Class 2 Bluetooth radio with a maximum range (spherical radius) of
about 100 meters (328 feet). Obstacles and other conditions may affect range, and class
of operation and connection mode will impact battery life. See “S pecifications” fo r detailed
battery life information.

9

Operation Modes

Operation Modes

The WristOx2, Model 3150, has three states: Cable, Standby, and On.

Cable

The device is in Cable mode when it is connected to a PC using the USB interface cable.
While in Cable mode, the device does not collect or save data and the Bluetooth radio is
off.

Standby

When the device is in S tandby mode, the screen is blank and the device appears to be of f.
In Standby, it is ready for a signal that will turn the device on (e.g., pressing activation
switch, inserting finger in sensor [S pot Check mode], connecting sensor [Sensor Activation
mode], or programmed start time [Programmed mode]). While in Standby mode, the
device does not collect or save data and the Bluetooth radio is off.

On

When the device is on, it can collect and save data. The device features three turn on
modes:

• Spot Check mode

• Sensor Activation mode

• Programmed mode
The device is delivered in Spot Check mode . nV ISION software (version 6.3 or higher) is

needed to access the device settings and change Spo t Check mode to Sensor Activa tion
or Programmed mode (see “nVISION Software”).

The device recalls the active settings when the device is shut off and turned on again.

Spot Check Mode

Spot Check mode is the default turn on operation mode.
The device automatically turns on when a finger is inserted into the sensor. It enters

Standby mode 10 seconds after the finger is removed. If the sensor is disconnected, the
device enters Standby mode immediately.

In this mode, the sensor can be left connected to the device.

NOTE: If the device determines that a sensor fault exists (a sensor failure, misalignment,
or incompatibility with the device) or if a pulse oximeter sensor signal cannot be
detected, the device enters Standby mode after 3 minutes.

10

Operation Modes

Full Display

Partial Display

Sensor Activation Mode

Sensor Activation mode may be selected through nVISION software. In this mode, the
device turns on when the activation switch is pressed or when the sensor is disconnected
and reconnected. This mode is useful when using a sensor that is not easily remove d from
the sensor site (e.g., disposable or wrap sensor).

NOTE: The sensor doe

If the sensor is not used for at least 10 minutes or if an

s not need to be applied to a finger to turn the device on.

inadequate pulse signal is detected,
the device automatically enters Standby mode. To turn the device on again, press the
activation switch or disconnect and reconnect the sensor.

This mode allows for Full or Partial display (see figure 2 for display comparison). When
using Partial d

isplay, the SpO

and pulse rate readings do not display. The user will only

2

see the battery indicator and the animated pulse strength indicator.

Figure 2: Comparison of Full and Partial Display

Programmed Mode

Programmed mode may be selected and setup through nVISION software. With the
software, the user can program the device to start and stop for up to three sessions. Once
programmed, the next start time displays on the LCD every 30 seconds in HH:MM format.

A sensor must be connected for Programmed mode to function.
If the programmed device is in St andby mode and the a

ctivation switch is pressed, the user
activates the Bluetooth radio and the device for 3 minutes. During this time, the user is able
to take and store measurements. After 3 minutes, the device returns to Standby mode.

This mode allows for Full or Partial display (see figure 2 above for display comparison).
When

using Partial display , the SpO

and pulse rate readings do not display. The user will

2

only see the battery indicator and the animated pulse strength indicator.

NOTE: A programmed device reverts to Spot Check mode if the clock is not set or if the
clock settings are lost when replacing the batteries.

11

Using the WristOx2, Model 3150

Using the WristOx2, Model 3150

WARNING: Do not use the device when alarms are required.

W

ARNING: The USB cable must be unplugged from the device before replacing

batteries.

Installing Batteries

1. Open the battery compartment by sliding the battery door off the back of the 
device (figure 3).

Figure 3: Remove Battery Door

2. Insert 2 new AAA alkaline batteries (figure 4). Battery orient
inside the battery compartment.

3. Replace battery door by sliding it back into place.

4. Inserting batteries does not turn the device on. In Spot Check mode, the device 
turns on when a finger is inserted in the sensor.

NOTE: When batteries are removed, the device maintains the time and date for up to 
30 seconds. If replacing batteries takes more than 30 seconds, or if the battery level is 
at or below the critical level, the operation mode reverts to Spot Check mode. Use
nVISION software to reset the clock and change the operation mode.

Figure 4: Insert Batteries

ation is shown 

12

Using the WristOx2, Model 3150

Attach this end to strap
bar by sensor port

Fastener

Hook and Loop Side

Woven Side

Wrist Straps

The WristOx2, Model 3150, is designed to be applied to the patient’s wrist using a two­piece wrist band. The two-piece wrist band consists of a ring strap and an adjustable strap.

For pediatrics and petite adults, the device may b

e applied using a single adjustable strap.
The single adjustable strap is the longer of the two straps in the two-piece wrist band
package.

Straps have hook and loop fasteners on one side. The other side has a smooth, woven
fabric. Wh

en the straps are attached to the device, the woven side should touch the

patient’s skin.

NOTE: A wrist strap has a maximum of 10 uses before replacement is required.

This section contains descriptions of the straps and instructions for atta ching the straps to
the de

vice. See the “Patient Application” section for instructions on how to apply the device

to the patient.

Ring Strap Description

One end of the ring strap has a plastic ring. The square end has a hook and loop faste ner
(figure 5).

The square end attaches to the strap bar at the top of the device, by the sensor port
(see “Attach Ring Strap to Device”).

Figure 5: Ring Strap

13

Using the WristOx2, Model 3150

Strap bar at 
top of device 
(by sensor port)

Attach Ring Strap to Device

1. Place device face down.

2. Locate strap bar at top of device (by sensor port).

3. Position ring strap so hook and loop side of strap faces up.

4. Thread square end fastener through the strap bar by the sensor port. Start from
the back of the device and thread it towards the front of the device (figure 6).

.

5. Fold strap so fastener adheres to the strap (figure 7).

Figure 6: Thread Ring Strap

Figure 7: Attach Ring Strap

6. Continue to “Attach Adjustable Strap to Device.”

14

Using the WristOx2, Model 3150

Hook and Loop Side

Woven Side

Attach square end
to strap bar by
battery door

Rounded End Fastener

Square End
Fastener

Adjustable Strap Description

This strap is part of the two-piece wrist band and may also be used to apply the device
using a single strap.

The adjustable strap is available in various length

s (see “Parts and Accessories”). It has

hook and loop fasteners at both ends (figure 8).
The square end attaches to the strap bar at the bottom of the device, by the battery door

“Attach Adjustable Strap to Device” section).

(see

Attach Adjustable Strap to Device

1. Place device face down.

2. Locate strap bar at bottom of device (by battery door).

3. Position adjustable strap so hook and loop side of strap faces up.

Figure 8: Adjustable Strap

15

Using the WristOx2, Model 3150

Strap bar by
battery door

4. Thread square end fastener through the strap bar by the battery door. Start from 
the back of the device and thread it towards the front of the device (figure 9).

Figure 9: Thread Adjustable Wrist Strap

5. Fold square end of strap so square end fastener adheres to the strap (figure 10).

Figure 10: Attach Adjustable Wrist Strap

16

Using the WristOx2, Model 3150

Front View

Back View

6. Verify straps are attached properly (figure 11). The smooth, woven side of the 
strap should contact the patient.

Figure 11: Device with Wrist Straps Attached (Front and Back Views)

17

Using the WristOx2, Model 3150

!

Attaching the Sensor

When applying the device using a single strap, connect the sensor to the device after the
device has been applied to the patient (see “Single Strap Application”).

When using a two-piece wrist band, the sensor can be connected to the device before or
af

ter applying the device to the patient (see “Two-Piece Wrist Band Application”).

The following steps apply to these Nonin sensors:

• 8000SS-WO2, 8000SM-WO2, 8000SL-WO2

• 8000AA-WO2

• 8000J-WO2
If using another Nonin-branded sensor, use sensor adap

ter cable 3150I (see “Parts and

Accessories”).

CAUTION: Only use Nonin-branded sensors with a length of 1 meter or less.
Accuracy may degrade if sensor cable is over 1 meter in length. Using the sensor
cable adapter does not affect accuracy.

1. Insert the sensor connector into the sensor port at the top of the device (figure 12).
The Non

in logo on the sensor connector should face the front of the device.

2. Push the connector until it clicks into place.

3. The device is ready to use.

18

Figure 12: Attach Sensor

Using the WristOx2, Model 3150

Back View

Front View

Patient Application

The WristOx2, Model 3150, is usually worn on the back of a patient’s wrist. This section
describes how to secure the device to a wrist using either the two-piece wrist band or a
single strap.

NOTE: Straps can be used to secure the device to an alternate location (e.g., the upper
arm or a bed rail). See “Part and Accessories” for additional strap lengths.

Two-Piece Wrist Band Application

NOTE: Ensure the wrist band fits comfortably on the patient’s arm. Do not over-tighten

the wrist band.

1. Verify the ring strap and the adjustable strap have been attached properly to the
device (figure 13). If straps have not been attached to the device, see “Attach Ring
Strap to Device” and “Attach Adjustable Strap to Device.”

Figure 13: Verify Two-Piece Wrist Band Attachment

19

Using the WristOx2, Model 3150

Fastener

Plastic

Ring

2. Place the device on the back of the patient’s arm.

3. Thread the rounded end of the adjustable strap through the plastic ring on the ring
stra

p. Pull the adjustable strap through the plastic ring until the device fit s comforta bly

on the wrist (figure 14).

Figure 14: Thread and Tighten Two-Piece Wrist Band

4. Fold the adjustable strap back over the plastic ring and attach the fastener to the

able strap (figure 15).

adjust

Figure 15: Fasten Two-Piece Wrist Band

5. Attach the sensor if it is not already connected (see “Att

6. Apply the sensor to the patient (figure 16). Refer
proper sensor application sites and sensor application cautions and warnings.

20

aching the Sensor”).

to the sensor Instructions for Use for

Using the WristOx2, Model 3150

Front View

Back View

Figure 16: Apply Sensor to Patient

7. When in Spot Check mode, inserting a finger in the sensor automatically turns the
device

on. When the finger is removed, the device enters Standby mode in

approximately 10 seconds.

NOTE: Depending on the sensor and ambient light conditions, it may take up to 3 minutes
for the device to enter Standby mode.

8. If the device does not turn on, verify battery orientation, operation mode, and sensor

Single Strap Application

NOTE: Patients using a single strap may need assistance applying the device.

NOTE: Ensure the wrist band fits comfortably on the patient’s arm. Do not over-tighten

the wrist band.

1. Verify the adjustable strap has been attached to the device by the battery door 

con

nection. Refer to “Troubleshooting” for additional information.

(figure 17). If strap has not been attached, see “Attach Adjustable Strap to Device.”

Figure 17: Verify Single Strap Attachment

21

Using the WristOx2, Model 3150

2. Place the device on the back of the patient’s arm and wrap the strap around the
patient’s arm.

3. Thread the rounded end of the strap through the strap bar by the sensor port (figure 18).
S

tart from the back of the device and pull it towards the front of the device.

Figure 18: Thread Single Strap

4. Pull the strap through the strap bar until the device fits comfortably on the patient’s
wrist (figure

19).

Figure 19: Tighten Single Strap

22

Using the WristOx2, Model 3150

5. Fold the strap over the strap bar so the fastener attaches to the strap (figure 20).

Figure 20: Fasten Single Strap

6. Attach the sensor by inserting the sensor connector into the sensor port at the top of
evice. The Nonin logo on the sensor connector should face the front of the

the d
device. (See “Attaching the Sensor” for more information.)

7. Push the connector until it clicks into place.

8. Apply the sensor to the patient (figure 21). Refer t o the sensor Instructions for Use for

prope

r sensor application sites and sensor application cautions and warnings.

Figure 21: Apply Sensor to Patient

9. When in Spot Check mode, inserting a finger in the sensor automatically turns the

device

on. When the finger is removed, the device goes into Standby mode in

approximately 10 seconds.

NOTE: Depe

nding on the sensor and ambient light conditions, it may take up to 3 minutes

for the device to enter Standby mode.

10. If the device does not turn on, verify battery orientation, operation mode, and sensor

nection. Refer to “Troubleshooting” for additional information.

con

23

Using the WristOx2, Model 3150

Verifying Operation

When the WristOx2, Model 3150, first turns on, it performs a startup sequence and self­test. It occurs:

• When a sensor is applied to a patient (Spot Check mode).

• When a sensor is attached to the device (Sensor Activation mode).

• At a programmed start time when a sensor is attached to the device (Programmed
mode).

• After the activation switch is pressed while the device is in Standby mode.

• After the device disconnects from nVISION (Bluetooth connection only).

Verify all indicators display d uring the startup sequence. Indicators ap pear in the following
order for 1 second each.

Startup Sequence and Self-Test

1. r and the software revision level:

2. All display icons:

3. Date/time using 24-hour clock format (MM:DD:YY:HH:MM) 
(example shows 23 April 2010 at 5:57 p.m.):

Month and Day Year 
(MM:DD) (YY)

Hour and Minutes
(HH:MM)

If the time is not set, the device displays 01:01:10:00:00.
If any indicator does not display, do not use the device. Contact Nonin Technical Service

for assistance.

24

Using the WristOx2, Model 3150

Activation Switch

The activation switch is located next to the sensor port at the top of the WristOx2, Model

3150. It is primarily used to:

• Activate the Bluetooth radio when the device is either on or in Standby.

• Activate the device when it is in Sensor Activation mode so the user does not need to disconnect
and reconnect the sensor.

It will also activate the device when it is in Spot Check and Programmed modes.

Activate Bluetooth Radio

When the device’s Bluetooth radio is on, a master device can connect to it. If a connection
is not made, the Bluetooth radio shuts down.

Pressing the activation switch turns the Bluetooth radio on for 3 minutes. The device will
remain on until the Bluetooth radio shuts down. For example, if in Sensor Activatio n mode,
unplugging the sensor will not put the device in Standby.

Activate Device

When in Sensor Activation mode, the device enters S tandby mode after 10 minutes without
a signal. Pressing the activation switch allows the user to turn the device on without
disconnecting and reconnecting the sensor.

Error Codes

This device includes error codes that indicate problems with the unit. When an error
occurs, the device displays the letters “Er” and a two-digit code (table 2).

Table 2: Error Codes

Error Code Description

01 Configuration sector error
02 Patient data pointer error

03

04 Data format 13 stored packet pointer error

05

Main memory pointer error (Device memory is intact; however, the most
recent session may be missing from the device.)

Main data format 13 pointer error (Device memory is inta ct; however, the
most recent stored measurement may be missing from the device.)

Some error codes may be corrected by the user. See “Troubleshooting” for more
information.

25

Troubleshooting

Problem Possible Cause Possible Solution

Troubleshooting

Device will not
activate.

%SpO
do not display.

Poor pulse signal
indicator displays.

Poor pulse signal
indicator displays
and
pulse strength
indicator shows two
bars or less.

and pulse rate

2

Batteries inserted wrong. Check batteries.
Batteries are depleted. Replace batteries.
Sensor is disconnected. Reconnect sensor.
Device is in Sensor Activation

mode and has timed out.

Device is in Programmed mode. Use nVISION software to select Spot

Device set in Partial Display
mode.

Excessive patient motion. Reduce patient motion.

Inadequate pulse signal. Reposition or replace sensor , or place

Hands are cold. Warm sensor application site.

Press the activation switch.
Disconnect and then reconnect the

sensor.

Check or Sensor Activation mode.
Use nVISION software to select Full

Display mode. Reconnect sensor.

sensor on a different finger.
Remove and reconnect sensor .

No pulse display on
pulse strength bar
graph indicator.

26

Sensor applied incorrectly. Refer to sensor Instructions for Use

for proper sensor application.
Device needs repair. Contact Nonin Technical Service.
Possible interference from blood

flow restrictors (arterial catheters,
blood pressure cuffs, infusion
lines, etc.).

Reduced circulation due to excess
pressure from sensor.

Excessive ambient light. Shield sensor from light source.

Reduce or eliminate restriction.

Check sensor alignment, reposition

sensor, verify correct sensor size.

Check sensor alignment.

Troubleshooting

Problem Possible Cause Possible Solution

No pulse display on
pulse strength
indicator (continued).

Er 01 displays on
LCD.

Er 02 or 04 displays
on LCD.

Er 03 or 05
displays on LCD.

Dashes continually
display on LCD.

Device does not
record in
Programmed mode.

Sensor applied to polished or
artificial nail.

Sensor Light-Emitting Diode
(LED) is not lit.

Device configuration memory
failure.

Device memory failure. Contact Nonin Technical Service.

Device failure. Device memory
intact, but device may have lost
most recent session or stored
data.

Sensor malfunction. Replace sensor with a Nonin-branded

Data collection start and stop
times are set incorrectly.

Clock settings are lost after
replacing batteries.

Remove fingernail polish or an

artificial nail.

Contact Nonin Technical Service.

Device reverts to default settings

(Spot-Check mode, 4-second sample

rate). Use nVISION software to

change settings. If error code

continues, contact Nonin Technical

Service.

If error code continues, contact Nonin

Technical Service.

sensor.

Use nVISION software to program

correct start and stop times.

Use nVISION software to reset clock.

Devices will not pair. Device is out of range. Verify device is in range while being

paired (approximately 100 meters

[328 feet] spherical radius).
Bluetooth radio has timed out. Press activation switch to turn on

Bluetooth radio.

If these solutions do not correct the problem, please contact Nonin Technical Service at
(800)

356-8874 (USA and Canada) or + 1 [phone].

27

Care and Maintenance

!

Care and Maintenance

The device requires no calibration or maintenance other than battery replacement.

Cleaning the Device

Wipe the device with a soft cloth dampened with a 10% bleach solution. Do not use
undiluted bleach or any cleaning solution other than those recommended here, as
permanent damage could result. Dry with a soft cloth, or allow to air dry.

Clean once per week or more frequently if handled by multiple users.

CAUTION: Do not place the WristOx2, Model 3150, in liquid or clean it with agents
containing ammonium chloride or isopropyl alcohol.

Cleaning the Sensor

Refer to the sensor Instructions for Use for cleaning information.

Cleaning the Wrist Band

The wrist band is designed for single-patient use and may be used up to 10 times. 
If it needs to be cleaned, hand wash with a mild detergent (see note) in cool water (30 °C/
86 °F). Allow to a

Do not machine wash or dry. The wrist band will shrink if placed in a dryer.

NOTE: Mild
and grease. To clean washable surfaces, use in a solution of warm water.

CAUTION: Use a
can be high sudsing, so use sparingly. Wipe with a damp, detergent free cloth to remove
residue.

ir dry.

detergents, such as hand and dish washing liquid detergents, dissolve dirt

detergent that is safe for skin and washable surfaces. Most detergents

Storing

Store the device within the stated environmental specifications. See “Specifications” for
additional information.

Remove the batteries and disconnect the sensor if it is to be stored for more than 1 month.

28

Memory and Data

Memory and Data

The WristOx2, Model 3150 measures, collects, and stores up to 1,080 hours 
of SpO2 and pulse rate data with a 4-second data collection rate. Data collected at a 
1 or 2-second rate reduces memory capacity to 270 or 540 hours, respectively.

When the memory is full, the device overwrites the oldest existing data with the new data.
Each time the device is turned on, data are automatically stored in memory . Dat a collection
of less than 1 minute is not retained in memory.

Each time the device turns on, the current oximeter time and date (if the clock is set
properly) are stored in memory to allow quick differentiation of recording sessions. Patient
SpO

and pulse rate are stored every 4 seconds (default), or every 1 or 2 seconds if

2

programmed using nVISION software. The oxygen saturation values are stored in
1% increments in the range of 0 to 100%.

This device contains non-volatile memory . Removing or replacing batteries does not affect
the data stored in memory . S tored dat a remains in memory until overwritten by newer data
or cleared from memory with nVISION software.



NOTE: Downloading data in memory does not clear memory. To clear memory, see
“nVISION Settings.”

29

nVISION Software

nVISION Software

Nonin’s nVISION software (version 6.3 or greater) works with Microsoft Windows® 2000/
XP/Vista/7 operating systems. It allows users to transfer recorded patient data from the
device to a PC and then analyze, report, and archive the data. T he software is required t o
access the device’s additional modes of operation and advanced features.

nVISION Settings

The following WristOx2, Model 3150, settings are programmed using nVISION:

• Date and time – 24-hour clock format

• Display options – allows clinicians to choose the best display option for each patient:

• Full display shows %SpO2 and pulse rate data

• Partial display shows pulse strength indicator, but not %SpO

• Patient data storage (sample) rate – 1, 2, or 4 seconds

and pulse rate data

2

• Operation Modes – Sensor Activation, Spot Checking, and Programmed (see
“Activation Options”)

• Patient ID – up to 50 alphanumeric characters

• Bluetooth Radio – disable at startup

• Synchronize device time/date to the PC time/date

• Download and save patient data to a PC

• Clear device memory

T o access nVISION settings, connect the device to a PC using either the PC USB interface
cable or a Bluetooth connection.

Accessing nVISION Settings

1. Connect the device to a PC using the USB interface cable (see “Cable Connection”)

or Bluetooth (see “Bluetooth Connection”).

2. Open nVISION.

3. Click the Data Capture icon, or select New Data Capture from the File drop down

menu.

4. Select 3150 from the list of oximeters.

5. Click Settings.

6. “Enter Wrist Oximeter Settings” window opens (figure 22). Update or cha nge settings

as needed.

7. Click OK.

8. For more information, see nViSION Help.

30

nVISION Software

.

Figure 22: nVISION Settings Window

Cable Connection

To connect the device to a PC, use the PC USB interface cable found in the starter kit.
Once connected to a PC, the device settings may be accessed and data can be
downloaded using nVISION software.

The USB driver software for the cable needs to be installed before the device can connect
to the

PC. The software is located in the USB Driver folder on the Operator’s Manual CD.

1. Install USB driver if needed. See appropriate “USB Drive
more information.

2. Connect the cable to the USB port on the PC.

3. Connect the cable to the device’s sensor port.

r Installation” section for

31

nVISION Software

4. When the device is ready to use with nVISION, these indicators display on the LCD:

• CP

• Battery indicator

5. For more information about nVISION, refer to nVISION Help.
NOTE: Disconnect the USB interface cable from the device when the data transfer or

device configuration is complete. Leaving the cable connected will reduce battery life.

USB Driver Installation (XP)

1. The USB driver software is on the Operator’s Manual CD. Insert the CD into the PC’s

CD-DVD drive.

2. Connect the USB cable to the sensor port on the device and a USB port on the PC.

3. The Found New Hardware wizard opens and asks if Windows should connect to

Windows Update to search for software. Select No, not this time and click Next.

4. Select Install from a list or specific location (Advanced) and click Next.

5. When asked to choose search and installation options:

a. Select Search for the best driver in these locations.
b. Unselect Search removable media
c. Select Include this location in the search:
d. Browse to the USB Driver folder on the Operator’s Manual CD and click OK.
e. Click Next.

6. If the Hardware Installation/Windows logo testing window appears, click Continue

Anyway to continue the installation.

7. When the wizard is done with the software installation, click Finish.

8. Look up the communications (comm or COM) port for the device:

a. Click Start / Settings / Control Panel.
b. Select System. System Properties window opens.
c. On the Hardware tab, select Device Manager.
d. Expand Ports (COM & LPT). One port should say “Nonin Model 3150 (COM#).” 

Make a note of the COM#. It is needed to set up the device with nVISION.

32

nVISION Software

USB Driver Installation (Vista)

1. Connect the USB cable to the sensor port on the device and a USB port on the PC.

2. In the Found New Hardware window, select Locate and install driver software
(recommended).

3. Windows needs your permission to continue pop up appears. Continue with
installation.

4. The USB driver software is on the Operator’s Manual CD. Insert the CD into the PC’s
CD-DVD drive and click Next.

5. Update Driver Software - Model 3150 window opens. Choose Browse my computer
for driver software.

6. Browse to the USB Driver folder on the Operator’s Manual CD and click OK.

7. Click Next.

8. In the Windows Security pop-up window, select Install this driver software anyway.

9. Driver software installs. When Windows has successfully update d the driver software,
click Close.

10. Open the Device Manager by clicking Start / Control Panel / Device Manager.

11. In the Device Manager window, look up the communications (comm or COM) port for the
device. Expand Ports (COM & LPT). One port should say “Nonin Model 3150 (COM#).”
Make a note of the COM#. It is needed to set up the device with nVISION.

USB Driver Installation (Windows 7)

1. The USB driver software is on the Operator’s Manual CD. Insert the CD into the PC’s
CD-DVD drive.

2. Connect the USB cable to the sensor port on the device and a USB port on the PC.

3. Open the Device Manager by clicking Start / Control Panel / System and then
selecting Device Manager.

4. Expand Other devices.

5. Right click Model 3150 and select Update Driver Software...

6. Update Driver Software - Model 3150 window opens. Choose Browse my computer
for driver software.

7. Browse to the USB Driver folder on the Operator’s Manual CD and click OK.

8. Click Next.

9. In the Windows Security pop-up window, select Install this driver software anyway.

10. Driver software installs. When Windows has successfully updated the driver software ,
click Close.

11. In the Device Manager window, look up the communications (comm or COM) port for the
device. Expand Ports (COM & LPT). One port should say “Nonin Model 3150 (COM#).”
Make a note of the COM#. It is needed to set up the device with nVISION.

33

nVISION Software

Bluetooth Connection

NOTE: Etched onto the device is the word “pin” followed by a 6-digit number. This is the
device’s unique identification number, also known as the Bluetooth Passkey or PIN
Code. This number is used when pairing the device to the host system. Refer to the host
system’s operator’s manual for additional information.

Before a Bluetooth master device can connect with the WristOx2, Model 3150 (slave
device), the devices must be paired. Once paired, the WristOx
automatically connect with the last paired master device when turned on or activated.

1. To connect the WristOx2, Model 3150, to a PC or another device using Bluetooth, see
Nonin’s online Bluetooth Connection Tutorial:

http://www.nonin.com/training/products/3150/bluetooth_connection_tutorial/

2. When nVISION connects to the WristOx2, Model 3150, the device stops recording
patient data and the following indicators display on the LCD:

, Model 3150, will

2

• CP

• Battery indicator

• Bluetooth icon with animated bars

3. For more information about nVISION, refer to nVISION Help.

34

Parts and Accessories

Parts and Accessories

For more information about Nonin parts, acce ssories and sensors, contact your distributor ,
or contact Nonin at [phone] (USA and Canada) or [phone]. This
information is also available on Nonin’s website: www.nonin.com.

Model Number Description

3100CC Carrying Case
3150 Manual CD with Operator’s Manual and USB Driver Software
3150SC PC USB Interface Cable
nVISION nVISION Software (version 6.3 or greater). Used with Microsoft

Windows 2000/XP/Vista/7 operating systems.

3150I Sensor Adapter Cable. Used to connect 1-meter, 9-pin connector

sensors to the WristOx
sensors, contact Nonin, your distributor, or visit www.nonin.com.

, Model 3150. For compatible 1-meter

2

3150WB Two-piece Wrist Band. Available lengths:

6 in. (15 cm)
8 in. (20 cm)
10 in. (25 cm)
13 in. (33 cm)

3150WBE Wrist Band Extender, 5 in. (13 cm)

Reusable Pulse Oximeter Sensors

8000AA-WO2 Adult Articulated
8000J-WO2 Adult Flex Sensor
8000SS-WO2 Soft Sensor Small
8000SM-WO2 Soft Sensor Medium
8000SL-WO2 Soft Sensor Large

Finger Clip Sensor

35

Service, Support, and Warranty

Service, Support, and Warranty

Service and Support

For information about the device and accessories, contact your local sales represent ative
or distributor. For the sales representative or distributor in your area, contact Nonin.

A return authorization number is required before returning any product to Nonin. To obtain
this return authorization number, contact Nonin’s Technical Service Department at:

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, Minnesota 55441-5443 USA

[phone] (USA and Canada)

+ 1 [phone]

Fax: + 1 [phone]

E-mail: [e-mail]

www.nonin.com

Warranty

NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser the Model 3150,
WristOx
WristOx
which NONIN has been notified by the purchaser by serial number that there is a defect, provided
said notification occurs within the applicable warranty period. This warranty shall be the sole and
exclusive remedy by the purchaser hereunder for any WristOx
purchaser that is found to be defective in any manner , whether such remedies be in contract, tort,
or by law.

This warranty excludes cost of delivery to and from NONIN. All repaired units shall be received by
the purchaser at NONIN’s place of business. NONIN reserves the right to charge a fee for a
warranty repair request on any unit found to be within specifications.

The WristOx2, Model 3150, is a precision electronic instrument and must be repaired by
knowledgeable and specially trained NONIN personnel only. Accordingly, any sign or evidence of
opening the WristOx
of misuse of the WristOx

All non-warranty work shall be performed according to NONIN standard rates and charges in
effect at the time of delivery to NONIN.

DISCLAIMER/EXCLUSIVITY OF WARRANTY:

Pulse Oximeter for 3 years from the date of purchase. NONIN shall rep air or replace any

2

, Model 3150, found to be defective in accordance with this warranty, free of charge, for

2

, Model 3150, delivered to the

2

, Model 3150, field service by non-NONIN personnel, t ampering, or any kind

2

, Model 3150, shall void the warranty.

2

THE WARRANTIES IN THIS MANUAL ARE EXCLUSIVE, AND NO OTHER WARRANTIES OF
ANY KIND, WHETHER STATUTORY, WRITTEN, ORAL, OR IMPLIED, SHALL APPLY.

36

Technical Information

Technical Information

Manufacturer’s Declaration

Refer to the following table for specific information regarding this device’s compliance to
IEC 60601-1-2.

Table 3: Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment—Guidance

This device is intended for use in the electromagnetic environment specified below

The customer and/or user of this device should ensure that it is used in such an environment.

RF Emissions 
CISPR 11

RF Emissions
CISPR 11

Harmonic
Emissions
IEC 61000-3-2

Voltage
Fluctuatio
Flicker Emissions
IEC 61000-3-3

ns/

Group 2 This device must emit electro

to perform its intended function. Nearby electronic
equipment may be affected.

Class B This device is suitable for use in all establishments,

includ

ing domestic and those directly connected to the

N/A

N/A

public low-voltage power supply network that supplies
buildings used for domestic purposes.

magnetic energy in order

.

37

Technical Information

Table 4: Electromagnetic Immunity

Immunity

Test

This device is intended for use in the electromagnetic environment specified below

The customer and/or user of this device should ensure that it is used in such an environment.

Electrostatic
Disch

arge (ESD)

IEC 61000-4-2

Electrical Fast

ransient/Burst

T
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, short
in

terruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11

Power Frequency
(50/60 Hz) Magnetic

ld

Fie
IEC 61000-4-8

NOTE: U

is the AC mains voltage before application of the test level.

T

IEC 60601
Test Level

Compliance

Level

Electromagnetic

Environment—Guidance

.

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
relative humidity should be at
least 30%.

±2 kV for power supply
lines
±1 kV for input/output lines

±1 kV differential mode
±2 kV common mode

N/A Mains power quality should be

that of a typical commercial or
hospital environment.

N/A Mains power quality should be

tha

t of a typical commercial or

hospital environment.

±5% U

(>95% dip in UT)

T

for 0.5 cycle
±40% U

(60% dip in UT)

T

N/A Mains power quality should be

tha

t of a typical commercial or

hospital environment.
for 5 cycles
±70% U

(30% dip in UT)

T

for 25 cycles
<5% U

(>95% dip in UT)

T

for 5 sec.
3 A/m 3 A/m Power frequency magnetic fields

should be at levels c

haracteristic
of a typical location in a typical
commercial or hospital
environment.

38

d 1.17 P=

d 1.17 P=

d 2.33 P=

Technical Information

Table 5: Guidance and Manufacturer’s Declaration—

Electromagnetic Immunity

Immunity Test IEC 60601 Test

Level

This device is intended for use in the electromagnetic en

Compliance

Level

Electromagnetic Environment—

Guidance

vironment specified below.

The customer and/or user of this device should ensure that it is used in such an environment.

Portable and mobile RF communications equipm ent sh ou ld be use d no close r to any part of the devic e,
includ

ing cables, than the recommended separation distance calculated from the equation applicable to

the frequency of the transmitter.

Recommended Separation Distance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80
MH

z

3 V/m
80 MHz to 2.5

z

GH

3 Vrms

3 V/m



3 V/m

80 kHz to 800 MHz
800 MHz to 2.5 GHz

where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

termined by an electromagnetic site survey

de
should be less than the compliance level in each
frequency range.

b

a

,

Interference may occur in the vicinity of
equipment marked with the symbol:

NOTES:

1. At 80 MHz and 800 MHz, the higher frequency ra nge ap p lies.

2. These guidelines may not apply in all situation

s. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

a. Field strengths from fixed transmitters, such as base st ations f or radio (cellular/ cordless) telephon es and land mobile radios, amateur radio, AM

and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is
used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abn ormal per formance is
observed, 
additional measures may be necessary, such a

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

s reorienting or relocating the device.

39

Technical Information

d 1.17 P=

d 1.17 P=

d 2.33 P=

Table 6: Recommended Separation Distances

This table details the recommended separation distances between portable and mobile RF
communications equipment and this device

This device is intended for use in an electromagnetic e

of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output

power of the communications equipment.

Separation Distance According to Frequency of Transmitter

Rated Maximum
Output Power

of

150 kHz to 80 MHz

Transmitter W

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.73
1 1.2 1.2 2.3
10 3.7 3.7 7.3
100 12 12 23
For transmitters rated at a maximum output power n

distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTES:

1. At 80 MHz and 800 MHz, the higher frequency range applies.

2. These guidelines may not apply in all situations. Electro
absorption and reflection from structures, objects, and people.

nvironment in which radiated RF disturbances are controlled. Users

80 MHz to 800 MHz

800 MHz to 2.5 GHz

ot listed above, the recommended separation

magnetic propagation is affected by

Equipment Response Time

SpO2 Values

Standard/Fast Averaged SpO

2

Pulse Rate Values Response Latency

Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats

Example - SpO2 Exponential Averaging

decreases 0.75% per second (7.5% over 10 seconds)

SpO

2

Pulse Rate = 75 BPM

40

Average Latency

4 beat exponential 2 beats

60

65

70

75

80

85

90

95

100

0.0

8.0

16.0

24.0

32.0

40.0

48.0

56.0

64.0

72.0

80.0

Time in seconds

SpO2

SaO2 Reference 4 B eat Average

Technical Information

Specific to this example:

• The response of the 4-beat average is 1.5 seconds.

Testing Summary

SpO2 accuracy and low perfusion testing was conducted by Nonin Medical, Inc., as
described below.

SpO2 Accuracy Testing

SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non­smoking, light- to dark-skinned subjects during motion and no-motion conditions in an
independent research laboratory. The measured arterial hemoglobin saturation value

) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value,

(SpO

2

determined from blood samples with a laboratory co-oximeter . The accuracy of the sensors
in comparison to the co-oximeter samples measured over the SpO
70 - 100%. Accuracy data is calculated using the root-mean-squared (A
subjects, per ISO 9919:2005, Medical Electrical Equipment—Particular requireme
the basic safety and essential performance of pulse oximeter equipment for medical use.

Pulse Rate Motion Testing

This test measures pulse rate oximeter accuracy with motion artifact simulation introduced
by a pulse oximeter tester . This test determines whether the oximeter meets the criteria of
ISO 9919:2005 for pulse rate during simulated movement, tremor, and spike motions.

Low Perfusion Testing

This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable
amplitude settings at various SpO
maintain accuracy in accordance with ISO 9919:2005 for heart rate and S pO
obtainable pulse amplitude (0.3% modulation).

levels for the oximeter to read. The oximeter must

2

range of 

2

rms

value) for all

nts for

at the lowest

2

41

Specifications

Oximeter Specifications

Technical Information

Oxygen Saturation Display Range: 0 to 100 % SpO

2

Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Displays:

Numeric: 3-digit LCD

Pulse Strength: Pulse Strength Bar Graph

Saturation Accuracy A

%SpO

: No Motion Motion

2

rms

a

:

70 % to 100 %

b

Low Perfusion
8000AA-WO2: ±2 units ±2 units ±2 units
8000J-WO2: ±3 units NA ±2 units
8000SM-WO2: ±2 units NA ±2 units

Pulse Rate Accuracy: ±3 units ±3 units ±3 units

c

Measurement Wavelengths and Output Power

:

Red: 660 nanometers @ 0.8 mW max. avg.

Infrared: 910 nanometers @ 1.2 mW max. avg.

a. ±1 A
b. SpO2 accuracy in motion specified for 8000AA-W sensor.
c. This information is especially useful for clinicians performing photodynamic therapy.

represents approximately 68% of measurements.

rms

42

Technical Information

System Specifications

Temperature:

Operating: -5 °C to 40 °C (23 °F to 104 °F)

Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F)

Humidity:

Operating: 10 % to 95 % noncondensing

Storage/Transportation: 10 % to 95 % noncondensing

Operating Altitude: Up to 12,192 meters (40,000 feet)
Operating Hyperbaric Pressure: Up to 4 atmospheres
Power Requirements: Two AAA (1.5V) alkaline batteries
Battery Life:

Storage: Approx. 9 months

Operating without Bluetooth: Approx. 48 hours (minimum) of continuous

operation

a

Approx. 8 hours minimum

Operating with Bluetooth radio – Class 1

:

Operating with Bluetooth radio – Class 2: Approx. 24 hours minimum

Dimensions (without sensor or strap): 51 mm x 73 mm x 19 mm (H x W x D)

(2.0 in. x 2.9 in. x 0.75 in.)

Weight (with batteries and wrist strap): 64.0 g (2.3 oz)
Memory:

Type: Non-volatile

Capacity: up to 1,080 hours (4 sec. data storage rate)

up to 540 hours (2 sec. data storage rate)
up to 270 hours (1 sec. data storage rate)

Classification per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL60601-1:

Type of Protection: Internally powered (battery power)
Degree of Protection: Type BF-Applied Part
Mode of Operation: Continuous
Enclosure Degree of Ingress Protection: IP33

a. When operating with Bluetooth, typical battery life may vary depending on proximity to host connection

and configuration of host-to-device communications. Times provided are minimum times for common
configurations.

43

Transmitter

Bluetooth Compliance: Version 2.0
Operating Frequency: 2.4 to 2.4835 GHz
Output Power: < 20 dBm
Operating Range: 100-meter (328-foot) radius indoors
Network Topology: Point-to-Point
Operation: Slave
Antenna Type: Internal
Modulation Type: Frequency Shift Keying

Frequency Hopping Spread Spectrum

Technical Information

Band Width: 1 MHz

44